Policy & Regulation
BeiGene Initiates First-in-Human Phase 1 Clinical Trial of Investigational TYK2 Inhibitor BGB-23339
23 November 2021 - - The first patient has been dosed in a Phase 1 clinical trial of BGB-23339, a potent, allosteric investigational tyrosine kinase 2 inhibitor internally developed by scientists of China-based biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160), the company said.


TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders, such as psoriasis and inflammatory bowel disease.

BGB-23339 is a potent, highly selective, investigational TYK2 inhibitor targeting the regulatory pseudokinase domain.

The first-in-human Phase 1 trial (NCT05093270) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of BGB-23339. The trial is expected to enroll up to 115 healthy volunteers in Australia and/or China.

In addition to its broad portfolio focused on hematological malignancies and solid tumors, BeiGene is applying its research excellence and clinical expertise to address inflammation and immunology, an area of high unmet medical need.

BeiGene's internally developed, highly selective next-generation BTK inhibitor Brukinsa (zanubrutinib) is currently being evaluated in a Phase 2 trial in patients with active proliferative lupus nephritis.

BGB-23339 is a potent, highly selective, allosteric, investigational tyrosine kinase 2 inhibitor discovered and being developed by BeiGene.

TYK2 is a member of the JAK family and functions as a critical mediator in cytokine signaling pathways implicated in multiple immune-mediated disorders.

Designed to target the regulatory pseudokinase domain on TYK2, BGB-23339 has demonstrated strong selectivity in preclinical studies with potent inhibition of interleukin -12, IL-23, and Type 1 interferons --pro-inflammatory cytokines that play a determinant role in the induction of inflammation.

BGB-23339 is currently being evaluated in a Phase 1 clinical study.

BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide.

BeiGene has a global team of over 7,700 colleagues across five continents.
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